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  • 1
    Online Resource
    Online Resource
    Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial)
    Springer Science and Business Media LLC ; 2022
    In:  BMC Psychiatry Vol. 22, No. 1 ( 2022-12)
    Details
    In: BMC Psychiatry, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2022-12)
    Abstract: Cognitive behavioural therapy (CBT) is the recommended first-line treatment for children and adolescents with obsessive-compulsive disorder (OCD), but evidence concerning treatment-specific benefits and harms compared with other interventions is limited. Furthermore, high risk-of-bias in most trials prevent firm conclusions regarding the efficacy of CBT. We investigate the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation and relaxation training (FPRT) in youth with OCD in a trial designed to reduce risk-of-bias. Methods This is an investigator-initiated, independently funded, single-centre, parallel group superiority randomised clinical trial (RCT). Outcome assessors, data managers, statisticians, and conclusion drawers are blinded. From child and adolescent mental health services we include patients aged 8–17 years with a primary OCD diagnosis and an entry score of ≥16 on the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). We exclude patients with comorbid illness contraindicating trial participation; intelligence quotient 〈  70; or treatment with CBT, PRT, antidepressant or antipsychotic medication within the last 6 months prior to trial entry. Participants are randomised 1:1 to the experimental intervention (FCBT) versus the control intervention (FPRT) each consisting of 14 75-min sessions. All therapists deliver both interventions. Follow-up assessments occur in week 4, 8 and 16 (end-of-treatment). The primary outcome is OCD symptom severity assessed with CY-BOCS at end-of-trial. Secondary outcomes are quality-of-life and adverse events. Based on sample size estimation, a minimum of 128 participants (64 in each intervention group) are included. Discussion In our trial design we aim to reduce risk-of-bias, enhance generalisability, and broaden the outcome measures by: 1) conducting an investigator-initiated, independently funded RCT; 2) blinding investigators; 3) investigating a representative sample of OCD patients; 3) using an active control intervention (FPRT) to tease apart general and specific therapy effects; 4) using equal dosing of interventions and therapist supervision in both intervention groups; 5) having therapists perform both interventions decided by randomisation; 6) rating fidelity of both interventions; 7) assessing a broad range of benefits and harms with repeated measures. The primary study limitations are the risk of missing data and the inability to blind participants and therapists to the intervention. Trial registration ClinicalTrials.gov : NCT03595098, registered July 23, 2018.
    Type of Medium: Online Resource
    ISSN: 1471-244X
    URL: Article
    DOI: 10.1186/s12888-021-03669-2
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2050438-X
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  • 2
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    Correction: Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial)
    Springer Science and Business Media LLC ; 2022
    In:  BMC Psychiatry Vol. 22, No. 1 ( 2022-12)
    Details
    In: BMC Psychiatry, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2022-12)
    Type of Medium: Online Resource
    ISSN: 1471-244X
    URL: Article
    DOI: 10.1186/s12888-022-04142-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2050438-X
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  • 3
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    Collaboration for Evidence‐based Practice and Research in Anaesthesia ( CEPRA ): A consortium initiative for perioperative research
    Wiley ; 2023
    In:  Acta Anaesthesiologica Scandinavica Vol. 67, No. 6 ( 2023-07), p. 804-810
    Details
    In: Acta Anaesthesiologica Scandinavica, Wiley, Vol. 67, No. 6 ( 2023-07), p. 804-810
    Abstract: Evidence in perioperative care is insufficient. There is an urgent need for large perioperative research programmes, including pragmatic randomised trials, testing daily clinical treatments and unanswered question, thereby providing solid evidence for effects of interventions given to a large and growing number of patients undergoing surgery and anaesthesia. This may be achieved through large collaborations. Collaboration for Evidence‐based Practice and Research in Anaesthesia (CEPRA) is a novel collaborative research network founded to pursue evidence‐based answers to major clinical questions in perioperative medicine. The aims of CEPRA are to (1) improve clinical treatment and outcomes and optimise the use of resources for patients undergoing anaesthesia and perioperative care, and (2) disseminate results and inform caretakers, patients and relatives, and policymakers of evidence‐based treatments in anaesthesia and perioperative medicine. CEPRA is inclusive in its concept. We aim to extend our collaboration with all relevant clinical collaborators and patient associations and representatives. Although initiated in Denmark, CEPRA seeks to develop an international network infrastructure, for example, with other Nordic countries. The work of CEPRA will follow the highest methodological standards. The organisation aims to structure and optimise any element of the research collaboration to reduce economic costs and harness benefits from well‐functioning research infrastructure. This includes successive continuation of trials, harmonisation of outcomes, and alignment of data management systems. This paper presents the initiation and visions of the CEPRA network. CEPRA aims to be inclusive, patient‐focused, methodologically sound, and to optimise all aspects of research logistics. This will translate into faster research conduct, reliable results, and accelerated clinical implementation of results, thereby benefiting millions of patients whilst being cost and labour‐saving.
    Type of Medium: Online Resource
    ISSN: 0001-5172 , 1399-6576
    URL: Issue
    URL: Article
    DOI: 10.1111/aas.v67.6
    DOI: 10.1111/aas.14235
    RVK:
    XA 11250
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2004319-3
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  • 4
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    Protocol for an individual patient data meta‐analysis on blood pressure targets after cardiac arrest
    Wiley ; 2022
    In:  Acta Anaesthesiologica Scandinavica Vol. 66, No. 7 ( 2022-08), p. 890-897
    Details
    In: Acta Anaesthesiologica Scandinavica, Wiley, Vol. 66, No. 7 ( 2022-08), p. 890-897
    Abstract: Hypotension is common after cardiac arrest (CA), and current guidelines recommend using vasopressors to target mean arterial blood pressure (MAP) higher than 65 mmHg. Pilot trials have compared higher and lower MAP targets. We will review the evidence on whether higher MAP improves outcome after cardiac arrest. Methods This systematic review and meta‐analysis will be conducted based on a systematic search of relevant major medical databases from their inception onwards, including MEDLINE, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL), as well as clinical trial registries. We will identify randomised controlled trials published in the English language that compare targeting a MAP higher than 65–70 mmHg in CA patients using vasopressors, inotropes and intravenous fluids. The data extraction will be performed separately by two authors (a third author will be involved in case of disagreement), followed by a bias assessment with the Cochrane Risk of Bias tool using an eight‐step procedure for assessing if thresholds for clinical significance are crossed. The outcomes will be all‐cause mortality, functional long‐term outcomes and serious adverse events. We will contact the authors of the identified trials to request individual anonymised patient data to enable individual patient data meta‐analysis, aggregate data meta‐analyses, trial sequential analyses and multivariable regression, controlling for baseline characteristics. The certainty of the evidence will be assessed by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system. We will register this systematic review with Prospero and aim to redo it when larger trials are published in the near future. Conclusions This protocol defines the performance of a systematic review on whether a higher MAP after cardiac arrest improves patient outcome. Repeating this systematic review including more data likely will allow for more certainty regarding the effect of the intervention and possible sub‐groups differences.
    Type of Medium: Online Resource
    ISSN: 0001-5172 , 1399-6576
    URL: Issue
    URL: Article
    DOI: 10.1111/aas.v66.7
    DOI: 10.1111/aas.14090
    RVK:
    XA 11250
    Language: English
    Publisher: Wiley
    Publication Date: 2022
    detail.hit.zdb_id: 2004319-3
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  • 5
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    Interactions in the 2×2×2 factorial randomised clinical STEPCARE trial and the potential effects on conclusions: a protocol for a simulation study
    Springer Science and Business Media LLC ; 2022
    In:  Trials Vol. 23, No. 1 ( 2022-10-22)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 23, No. 1 ( 2022-10-22)
    Abstract: Randomised clinical trials with a factorial design may assess the effects of multiple interventions in the same population. Factorial trials are carried out under the assumption that the trial interventions have no interactions on outcomes. Here, we present a protocol for a simulation study investigating the consequences of different levels of interactions between the trial interventions on outcomes for the future 2×2×2 factorial designed randomised clinical Sedation, TEmperature, and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial in comatose patients after out-of-hospital cardiac arrest. Methods By simulating a multisite trial with 50 sites and 3278 participants, and a presumed six-month all-cause mortality of 60% in the control population, we will investigate the validity of the trial results with different levels of interaction effects on the outcome. The primary simulation outcome of the study is the risks of type-1 and type-2 errors in the simulated scenarios, i.e. at what level of interaction is the desired alpha and beta level exceeded. When keeping the overall risk of type-1 errors ≤ 5% and the risk of type-2 errors ≤ 10%, we will quantify the maximum interaction effect we can accept if the planned sample size is increased by 5% to take into account possible interaction between the trial interventions. Secondly, we will assess how interaction effects influence the minimal detectable difference we may confirm or reject to take into account 5% (small interaction effect), 10% (moderate), or 15% (large) positive interactions in simulations with no ‘true’ intervention effect (type-1 errors) and small (5%), moderate (10%), or large negative interactions (15%) in simulations with ‘true’ intervention effects (type-2 errors). Moreover, we will investigate how much the sample size must be increased to account for a small, moderate, or large interaction effects. Discussion This protocol for a simulation study will inform the design of a 2×2×2 factorial randomised clinical trial of how potential interactions between the assessed interventions might affect conclusions. Protocolising this simulation study is important to ensure valid and unbiased results. Trial registration Not relevant
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-022-06796-7
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2040523-6
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  • 6
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    Major mistakes and errors in the use of Trial Sequential Analysis in systematic reviews or meta-analyses – protocol for a systematic review
    Springer Science and Business Media LLC ; 2022
    In:  Systematic Reviews Vol. 11, No. 1 ( 2022-12)
    Details
    In: Systematic Reviews, Springer Science and Business Media LLC, Vol. 11, No. 1 ( 2022-12)
    Abstract: Adequately conducted systematic reviews with meta-analyses are considered the highest level of evidence and thus directly defines many clinical guidelines. However, the risks of type I and II errors in meta-analyses are substantial. Trial Sequential Analysis is a method for controlling these risks. Erroneous use of the method might lead to research waste or misleading conclusions. Methods The current protocol describes a systematic review aimed to identify common and major mistakes and errors in the use of Trial Sequential Analysis by evaluating published systematic reviews and meta-analyses that include this method. We plan to include all studies using Trial Sequential Analysis published from January 2018 to January 2022, an estimated 400 to 600 publications. We will search Medical Literature Analysis and Retrieval System Online and the Cochrane Database of Systematic Reviews, including studies with all types of participants, interventions, and outcomes. Two independent reviewers will screen titles and abstracts, include relevant full text articles, extract data from the studies into a predefined checklist, and evaluate the methodological quality of the study using the AMSTAR 2, assessing the methodological quality of the systematic reviews. Discussion This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols (PRISMA-P). The identified mistakes and errors will be published in peer reviewed articles and form the basis of a reviewed guideline for the use of Trial Sequential Analysis. Appropriately controlling for type I and II errors might reduce research waste and improve quality and precision of the evidence that clinical guidelines are based upon.
    Type of Medium: Online Resource
    ISSN: 2046-4053
    URL: Article
    DOI: 10.1186/s13643-022-01987-4
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2022
    detail.hit.zdb_id: 2662257-9
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  • 7
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    Standardized distances for placement of REBOA in patients with aortic stenosis
    Springer Science and Business Media LLC ; 2020
    In:  Scientific Reports Vol. 10, No. 1 ( 2020-08-07)
    Details
    In: Scientific Reports, Springer Science and Business Media LLC, Vol. 10, No. 1 ( 2020-08-07)
    Abstract: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a technique where a balloon is advanced through the common femoral artery and temporarily inflated for treatment of cardiac arrest or non-compressible haemorrhage. The aim of this study was to measure intravascular distances relevant for correct placement of the REBOA catheter using computer tomographic (CT) scans. In a series of CT scans of the aorta from 100 patients diagnosed with severe aortic stenosis planned for transcatheter aortic valve implantation, we measured the intravascular distance from the insertion site in the common femoral artery to two potential zones for placement of the REBOA catheter; between the left subclavian artery and the celiac trunk (Zone 1), as well as between the aortic bifurcation and the distal take-off of the renal arteries (Zone 3). The mean (± SD) intravascular distance from the femoral artery to intra-aortic Zone 1 was 36 (± 2.5) cm for the lower border and 60 (± 4.1) cm for the upper border, respectively. For intra-aortic Zone 3, the mean (± SD) intravascular distance was 21 (± 2.1) cm to the lower border and 31 (± 2.3) cm to the upper border. Calculated potentially safe intervals for placement of the REBOA in Zone 1 was with 99.7% likelihood between 43 and 48 cm. No similar potentially safe interval could be calculated for Zone 3. According to this cohort study of patients with severe aortic stenosis, the balloon of the REBOA catheter should travel intraarterially between 43 (lower limit) and 48 cm (upper limit) from the site of insertion into the common femoral artery, which would lead to correct placement in intra-aortic Zone 1 in 99.7% of cases. In contrast, no potential safety interval could be similarly defined for insertion in Zone 3.
    Type of Medium: Online Resource
    ISSN: 2045-2322
    URL: Article
    DOI: 10.1038/s41598-020-70364-9
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2615211-3
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  • 8
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    Diagnostic and prognostic performance of Mxa and transfer function analysis-based dynamic cerebral autoregulation metrics
    SAGE Publications ; 2022
    In:  Journal of Cerebral Blood Flow & Metabolism Vol. 42, No. 11 ( 2022-11), p. 2164-2172
    Details
    In: Journal of Cerebral Blood Flow & Metabolism, SAGE Publications, Vol. 42, No. 11 ( 2022-11), p. 2164-2172
    Abstract: Dynamic cerebral autoregulation is often assessed by continuously recorded arterial blood pressure (ABP) and transcranial Doppler-derived mean cerebral blood flow velocity followed by analysis in the time and frequency domain, respectively. Sequential correlation (in the time domain, yielding e.g., the measure mean flow index, Mxa) and transfer function analysis (TFA) (in the frequency domain, yielding, e.g., normalised and non-normalised gain as well as phase in the low frequency domain) are commonly used approaches. This study investigated the diagnostic and prognostic performance of these metrics. We included recordings from 48 healthy volunteers, 19 patients with sepsis, 36 with traumatic brain injury (TBI), and 14 patients admitted to a neurorehabilitation unit. The diagnostic (between healthy volunteers and patients) and prognostic performance (to predict death or poor functional outcome) of Mxa and the TFA measures were assessed by area under the receiver-operating characteristic (AUROC) curves. AUROC curves generally indicated that the measures were ‘no better than chance’ (AUROC ∼0.5) both for distinguishing between healthy volunteers and patient groups, and for predicting outcomes in our cohort. No metric emerged as superior for distinguishing between healthy volunteers and different patient groups, for assessing the effect of interventions, or for predicting mortality or functional outcome.
    Type of Medium: Online Resource
    ISSN: 0271-678X , 1559-7016
    URL: Article
    DOI: 10.1177/0271678X221121841
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2039456-1
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  • 9
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    An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial
    Springer Science and Business Media LLC ; 2021
    In:  Trials Vol. 22, No. 1 ( 2021-12)
    Details
    In: Trials, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2021-12)
    Abstract: Non-suicidal self-injury (NSSI) has a lifetime prevalence of 17% in adolescents in the general population and up to 74% in adolescents with psychiatric disorders. NSSI is one of the most important predictors of later suicidal behaviour and death by suicide. The TEENS feasibility trial was initiated to assess the feasibility and safety of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as an add-on to treatment as usual in 13–17-year-old patients with NSSI referred to the Child and Adolescent Mental Health Services. Methods The TEENS feasibility trial is a randomised clinical trial with a parallel-group design. The trial intervention is an 11-week online therapy which is tested as an add-on to treatment as usual versus treatment as usual. The primary feasibility outcomes are the fraction of participants who (1) completed 12 weeks of follow-up interview or assessment, (2) consented to inclusion and randomisation out of all eligible participants, and (3) were compliant with the experimental intervention, assessed as completion of at least six out of eleven modules in the programme. Since this is a feasibility trial, we did not predefine a required sample size. The exploratory clinical outcome, the frequency of NSSI episodes, assessed using Deliberate Self-Harm Inventory – Youth version (DSHI-Y), at the end of intervention, is planned to be the future primary outcome in a larger pragmatic definitive randomised clinical trial. After completion of the feasibility trial, blinded data will be analysed by two independent statisticians blinded to the intervention, where ‘A’ and ‘B’ refer to the two groups. A third party will compare these reports, and discrepancies will be discussed. The statistical report with the analyses chosen for the manuscript is being tracked using a version control system, and both statistical reports will be published as a supplementary material. Based on the final statistical report, two blinded conclusions will be drawn by the steering group. Discussion We present a pre-defined statistical analysis plan for the TEENS feasibility trial, which limits bias, p-hacking, data-driven interpretations. This statistical analysis plan is accompanied by a pre-programmed version-controlled statistical report with simulated data, which increases transparency and reproducibility. Trial registration ClinicalTrials.gov NCT04243603 . Registered on 28 January 2020
    Type of Medium: Online Resource
    ISSN: 1745-6215
    URL: Article
    DOI: 10.1186/s13063-021-05406-2
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
    detail.hit.zdb_id: 2040523-6
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  • 10
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    Automated pupillometry and the FOUR score — what is the diagnostic benefit in neurointensive care?
    Springer Science and Business Media LLC ; 2020
    In:  Acta Neurochirurgica Vol. 162, No. 7 ( 2020-07), p. 1639-1645
    Details
    In: Acta Neurochirurgica, Springer Science and Business Media LLC, Vol. 162, No. 7 ( 2020-07), p. 1639-1645
    Type of Medium: Online Resource
    ISSN: 0001-6268 , 0942-0940
    URL: Article
    DOI: 10.1007/s00701-020-04381-y
    RVK:
    XA 10000
    RVK:
    XA 12300
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 1464215-3
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